Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Dressing, Wound, Drug

FDA product code FRO · 659 cleared devices

Class U Unknown

Review panel: SU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-03-28 – 2026-09-22

FRO 2026-09-22

Actolind® (06.3637. Actolind® Gel Plus)

Applicant ACTO GmbH

K number K254168

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FRO 2026-09-11

SkinSmart Antimicrobial HydroGel

Applicant Magic Science Supply, LLC

K number K254041

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FRO 2026-08-14

Redermax® Antibacterial Wound Matrix

Applicant Beijing Kreate Medical Co., Ltd.

K number K261646

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FRO 2026-08-11

Vashe Plus Antimicrobial Solution

Applicant Urgo Medical North America, LLC

K number K253665

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FRO 2026-06-24

Microdacyn Wound Irrigation Solution

Applicant Sonoma Pharmaceuticals, Inc.

K number K261023

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FRO 2026-06-24

SilverCeuticals® Antimicrobial Wound Gel

Applicant Silverceuticals, Inc.

K number K251929

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FRO 2026-06-17

Bonvadis®

Applicant Oneness Biotech Co., Ltd.

K number K261638

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FRO 2026-05-13

StatSeal Disc

Applicant Merit Medical Systems, Inc.

K number K254073

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FRO 2026-04-07

IWD-Gel™

Applicant InnovaCorium, Inc.

K number K254191

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FRO 2026-03-25

MiraChlor Antimicrobial Wound Solution

Applicant Letus Corporation

K number K252023

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FRO 2026-03-13

Promogran Prisma™ Collagen Matrix with ORC and Silver

Applicant Solventum Germany GmbH

K number K251999

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FRO 2026-03-11

LUOFUCON® Antimicrobial Wound Gel

Applicant Huizhou Foryou Medical Co., Ltd.

K number K252028

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FRO 2026-02-02

Redermax Antibacterial Wound Matrix

Applicant Beijing Kreate Medical Co., Ltd.

K number K251582

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FRO 2026-01-23

New Day Skin Spray

Applicant Silk Holdings, Inc.

K number K252568

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FRO 2026-01-12

SBC1 Cream

Applicant Sioxmed, LLC

K number K250890

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FRO 2026-01-08

revyve® Antimicrobial Skin and Wound Cleanser

Applicant Kane Biotech, Inc.

K number K252759

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FRO 2026-01-05

Puracyn® Plus Antimicrobial Irrigation Solution

Applicant Innovacyn, Inc.

K number K251757

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FRO 2025-12-19

Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)

Applicant Qingdao Bright Moon Biomedical Materials Co., Ltd.

K number K252167

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FRO 2025-11-19

LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K250642

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FRO 2025-10-14

Hemastyl(™) Wound Dressing

Applicant Rapid Nexus Nanotech Wound Solutions, Inc.

K number K250115

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FRO 2025-10-10

Tegaderm Post-Op Transparent Antimicrobial Dressing

Applicant Solventum US, LLC

K number K251866

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FRO 2025-08-27

Dermalage

Applicant Infection Elimination Solutions, LLC

K number K243166

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FRO 2025-07-22

Granudacyn® Wound Irrigation Solution

Applicant P.G.F. Industry Solutions GmbH

K number K243415

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FRO 2025-06-09

Bonvadis®

Applicant Oneness Biotech Co., Ltd.

K number K251093

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FRO 2025-05-02

Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel

Applicant Seriously Clean, Ltd.

K number K243457

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FRO 2025-04-21

Spectricept Skin and Wound Cleanser

Applicant Spectrum Antimicrobials, Inc.

K number K243875

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FRO 2025-03-13

SiOxC Cream

Applicant Sioxmed, LLC

K number K242406

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FRO 2025-03-06

Sterile Water USP and Sterile 0.9% Normal Saline USP

Applicant Laboratorios Biogalenic S.A. DE C.V.

K number K243001

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FRO 2024-12-16

LUOFUCON® Silver Collagen Dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K240809

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FRO 2024-12-09

Atrauman® Ag

Applicant Hartmann USA, Inc.

K number K242758

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FRO 2024-11-13

LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K242856

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FRO 2024-11-08

Microdacyn Hydrogel

Applicant Sonoma Pharmaceuticals, Inc.

K number K240510

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FRO 2024-10-31

Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo

Applicant Bionova Medical, Inc.

K number K243181

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FRO 2024-10-21

Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch

Applicant Speciality Fibres and Materials, Ltd.

K number K222740

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FRO 2024-10-17

Microlyte Ag/Lidocaine

Applicant Imbed Biosciences

K number K211943

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FRO 2024-10-07

LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K240485

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FRO 2024-09-20

Derma-R Cream (Derma-R Cream)

Applicant Raya Pharmaceuticals, LLC

K number K240722

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FRO 2024-09-13

Microdacyn Wound Care Solution

Applicant Sonoma Pharmaceuticals, Inc.

K number K233399

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FRO 2024-08-21

Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo

Applicant Bionova Medical, Inc.

K number K240298

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FRO 2024-07-31

Silverlon® Wound Contact, Burn Contact Dressing

Applicant Argentum Medical, LLC

K number K241225

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FRO 2024-07-19

coactiv+™ Antimicrobial Wound Gel

Applicant Kane Biotech, Inc.

K number K241809

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FRO 2024-07-18

Field Shield Wound Dressing

Applicant Kericure, Inc.

K number K212521

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FRO 2024-06-18

Irrisept Antimicrobial Wound Lavage

Applicant Irrimax Corporation

K number K240552

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FRO 2024-05-31

Anti-bacterial bandage

Applicant Jinhua Jingdi Medical Supplies Co., Ltd.

K number K232333

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FRO 2024-05-31

Puracyn® Plus Antimicrobial Irrigation Solution

Applicant Innovacyn, Inc.

K number K232080

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FRO 2024-05-24

ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC

Applicant Foshan United Medical Technologies, Ltd.

K number K233111

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FRO 2024-05-22

Bonvadis®

Applicant Stemcyte, Inc.

K number K232655

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FRO 2024-03-27

LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K223360

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FRO 2024-03-26

PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)

Applicant Medline Industries, LP

K number K233151

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FRO 2024-03-22

Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)

Applicant Coloplast Corp.

K number K231953

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FRO 2024-01-11

Copper Foam Dressing (Prescription and OTC)

Applicant Roosin Medical Co., Ltd.

K number K231088

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FRO 2024-01-04

LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K221110

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FRO 2023-12-21

LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K223359

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FRO 2023-12-01

Antibacterial Gel Wound Dressing

Applicant Winner Medical Co., Ltd.

K number K231057

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FRO 2023-11-17

Polyver Silver Alginate Dressing (Prescription and OTC)

Applicant Roosin Medical Co., Ltd.

K number K230190

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FRO 2023-11-10

Skin and Wound Cleanser

Applicant Winner Medical Co., Ltd.

K number K231564

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FRO 2023-10-26

Antimicrobial Gelling Fiber Dressing with PHMB

Applicant Advanced Medical Solutions, Ltd.

K number K213473

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FRO 2023-10-13

APIS (R), VERIS (TM)

Applicant Sweetbio, Inc.

K number K222143

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FRO 2023-10-11

G4Derm / G4Derm Plus Synthetic Wound Matrix

Applicant Gel4med, Inc.

K number K222025

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FRO 2023-09-29

Antibacterial bandage

Applicant Allmed Medical Products Co., Ltd.

K number K221570

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FRO 2023-08-18

ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing

Applicant Smith & Nephew Medical Limited

K number K223526

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FRO 2023-06-21

Antibacterial Bandage

Applicant Winner Medical Co., Ltd.

K number K221311

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FRO 2023-05-24

coactiv+™ Antimicrobial Wound Gel

Applicant Kane Biotech, Inc.

K number K223259

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FRO 2023-04-05

Antimicrobial Silicone PHMB Foam Wound Dressing

Applicant Advanced Medical Solutions Limited

K number K223310

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FRO 2023-03-30

BIASURGE Advanced Surgical Solution

Applicant Rochal Technologies, LLC

K number K223377

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FRO 2023-03-16

Sterile Silver Alginate Wound Dressing

Applicant Qingdao Bright Moon Biomedical Materials Co., Ltd.

K number K220673

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FRO 2023-01-30

PHMB Wound Dressing

Applicant Winner Medical Co., Ltd.

K number K221532

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FRO 2023-01-17

Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)

Applicant Winner Medical Co., Ltd.

K number K221754

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FRO 2023-01-13

Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing

Applicant Winner Medical Co., Ltd.

K number K221755

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FRO 2023-01-13

Spectricept Skin and Wound Cleanser

Applicant Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.

K number K213514

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FRO 2022-12-21

Extra Silver Gelling Fiber Dressing

Applicant Winner Medical Co., Ltd.

K number K221720

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FRO 2022-12-21

ELECTROCYN soma

Applicant V3Bio Sdn. Bhd

K number K220286

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FRO 2022-10-26

Silverlon Wound Contact, Burn Contact Dressings

Applicant Argentum Medical, Inc.

K number K221218

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FRO 2022-10-18

MEBO Wound Dressing

Applicant Mebo Life Science, Inc.

K number K222657

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FRO 2022-08-19

Bonvadis Topical Cream

Applicant Stemcyte, Inc.

K number K212554

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FRO 2022-04-22

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K211123

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FRO 2022-03-23

LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K210718

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FRO 2022-02-24

PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing

Applicant 3M Healthcare Business Group

K number K210135

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FRO 2022-01-14

Silver Gelling Fiber Dressing

Applicant Winner Medical Co., Ltd.

K number K210466

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FRO 2021-10-19

Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)

Applicant Winner Medical Co., Ltd.

K number K202982

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FRO 2021-09-23

TorrentX Wound Wash

Applicant Next Science, LLC

K number K203446

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FRO 2021-09-01

Omeza Collagen Matrix

Applicant Omeza, LLC

K number K211972

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FRO 2021-05-12

High Performance Antimicrobial Gelling Fiber with Silver

Applicant Advanced Medical Solutions, Ltd.

K number K210974

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FRO 2021-04-23

MIS Solution

Applicant Next Science, LLC

K number K203835

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FRO 2021-04-14

AMSure® Single Use Saline Topical Solution

Applicant Amsino Medical, Inc.

K number K201138

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FRO 2021-02-05

Antibacterial Bandage

Applicant Jiangsu Excellence Medical Supplies Co., Ltd.

K number K201324

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FRO 2021-01-28

LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K201016

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FRO 2020-10-19

anti-bacterial bandage

Applicant Planet (Suzhou) Medical Products Co., Ltd.

K number K200821

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FRO 2020-10-08

SilverStream Gel

Applicant Enzysurge , Ltd.

K number K200767

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FRO 2020-09-04

3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad

Applicant 3M Company

K number K200835

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FRO 2020-09-04

MEBO Wound Dressing

Applicant Mebo Life Science, Inc.

K number K193439

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FRO 2020-09-03

HaloGUARD Protective Disc with CHG

Applicant Attwill Medical Solutions

K number K200641

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FRO 2020-06-17

LT Antibacterial Alginate with Silver Dressing

Applicant Zhejiang Longterm Medical Technology Co., Ltd.

K number K192478

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FRO 2020-05-14

PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border

Applicant Winner Medical Co., Ltd.

K number K192463

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FRO 2020-05-14

Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border

Applicant Winner Medical Co., Ltd.

K number K191819

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FRO 2020-05-11

PuraDERM Gel

Applicant 3-D Matrix, Inc.

K number K193085

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FRO 2020-03-11

AC5 Topical Gel

Applicant Arch Therapeutics, Inc.

K number K190129

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FRO 2020-02-21

Biatain Silicone Ag

Applicant Coloplast A/S

K number K191536

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FRO 2020-02-07

Rochal Antimicrobial Wound Gel

Applicant Rochal Industries, LLC

K number K192527

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FRO 2019-12-20

IODOFLEX

Applicant Smith & Nephew Medical, Ltd.

K number K190756

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